Tether line systems and methods for tongue or other tissue suspension or compression

ABSTRACT

Systems and methods of placing one or more suture loops into tissue, such as the base of the tongue, are described. A system can include a variable-thickness suspension line for suspending tissue, including a suture having a first thickness dimension; an elastomer surrounding a portion of the suture and defining a central segment of the suspension line having a second thickness dimension greater than the first thickness dimension, and at least one transition zone extending from the central segment of the suspension line to a lateral end of the suspension line, the transition zones having a thickness dimension that tapers from the second thickness dimension to the first thickness dimension.

PRIORITY CLAIM

This application claims priority under 35 U.S.C. §119(e) as anonprovisional application of U.S. Prov. Pat. App. No. 61/698,457 filedon Sep. 7, 2012, which is hereby incorporated by reference in itsentirety.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates generally to suture passer systems and methodsfor tissue suspension and tissue compression, and suspension lines,including embodiments with radially enlarged segments.

SUMMARY OF THE INVENTION

Disclosed herein are variable-thickness suspension line for suspendingtissue. The suspension lines can include a suture having a firstthickness dimension. In some embodiments, the suspension lines alsoinclude an elastomer surrounding a portion of the suture and defining acentral segment of the suspension line having a second thicknessdimension greater than the first thickness dimension. The suspensionlines can also include at least one transition zone extending from thecentral segment of the suspension line to a lateral end of thesuspension line, the transition zones having a thickness dimension thattapers from the second thickness dimension to the first thicknessdimension.

In some embodiments, the suspension lines include a plurality oftransition zones, each transition zone extending from the centralsegment of the suspension line to respective lateral ends of thesuspension line. The elastomer can be overmolded onto the suture. Theelastomer can be, for example silicone. The suture can be braided. Thesuspension line can also include a radiopaque marker operably attachedto the suture. The radiopaque marker can be disposed on, for example,the central segment of the suspension line. The suspension line canextend axially along the entire length of the suspension line. Theelastomer can be overmolded over a plurality of discontinuous segmentsof the suture. The central segment of the suspension line can includeone or more knots for improving adhesion between the suture and theelastomer. The suspension line could have a rounded, and/or arectangular cross-section. The central segment can be configured to movebetween a first axially unstretched configuration and a second axiallystretched configuration. In some embodiments, the first thicknessdimension can be less than about 0.020 inches. The second thicknessdimension can be between about 0.080 inches and about 0.120 inches. Anaxial length of the central segment can be between about 2 cm and about3 cm. An axial length of the transition zones can be less than about 1cm.

Also disclosed herein is a variable-thickness suspension line forsuspending tissue. The suspension line can include a tether having afirst thickness dimension. The tether can have first and second lateralends and a central segment. The suspension line can also have anelastomer surrounding and overmolded to the central segment of thetether and defining a central zone of the suspension line, the centralzone having a second thickness dimension greater than the firstthickness dimension.

In some embodiments, disclosed is a method for performing glossopexy.The method can include providing a variable-thickness suspension linecomprising: a suture having a first thickness dimension, the sutureextending axially along the suspension line; and an elastomersurrounding and overmolded to a segment of the suture, defining acentral segment of the suspension line having a second thicknessdimension greater than the first thickness dimension; and wherein areasof the suture not surrounded by the elastomer define lateral ends of thesuspension line; passing the suspension line through the base of thetongue to form a loop in the suspension line; and tensioning thesuspension line to suspend the tongue. The method can also includesecuring the suspension line to the mandible.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C illustrate one embodiment of a cammed bone anchor designthat has the advantage of eliminating the need to thread a tether.

FIGS. 2A-2F illustrate an embodiment of a bone anchor design configuredto secure a tether.

FIG. 3 illustrates an embodiment of a suspension line that includes atether, knots or other features to improve adhesion between the moldedsegment and the tether, a radio-opaque marker, and a molded segment.

FIG. 4 illustrates another embodiment of a suspension line.

FIGS. 5-6 illustrate embodiments of suture coil composite suspensionlines.

FIG. 7A-7E illustrate various elastic anchor embodiments.

FIGS. 7F-7G illustrate additional elastic embodiments.

FIGS. 8A-8D illustrate tethers including stretch elements that canprovide limited compliance to allow for easier swallowing while stillproviding suspension for sleep apnea resolution.

In some embodiments, as illustrated in FIGS. 9A-9B, the tether caninclude mechanical elements that can be drops of adhesive that wick intostructures of, e.g., ribbon or impregnated silicone, that may beessentially localized stiff sections.

FIG. 10 illustrates an additional suspension line embodiment.

FIG. 11 illustrates another suspension line embodiment.

FIG. 12 illustrates another embodiment of a suspension line.

FIGS. 13A-13B illustrate a suture loop placed in the tongue having asuture lock mechanism.

FIG. 14 illustrates a method of using one embodiment of a suture passersystem to create a suture loop having a vertical orientation.

FIG. 15 illustrates a method of using one embodiment of a suture passersystem to introduce serial spaced-apart or overlapping multiple sutureloops into tissue.

FIGS. 15A-15D illustrate a method of delivering a plurality of sutureloops into tissue having a common midline axis, according to oneembodiment of the invention.

FIG. 15E illustrates a method of accessing the tongue with pharyngealanatomy, according to one embodiment of the invention.

FIGS. 15F-15N illustrate one embodiment of a method to create a sutureloop in the base of the tongue.

FIGS. 15O-15R illustrate one embodiment of a method to create aplurality of suture loops in tissue.

FIGS. 15S-15W illustrate a method of passing a suture loop around astructure other than tissue, according to one embodiment of theinvention.

DETAILED DESCRIPTION

This application incorporates by reference in its entirety U.S. Pat.Pub. No. 2011/0245850 A1 to van der Burg et al. Embodiments of elementsdisclosed herein including bone anchors, suspension lines, and/or suturelock mechanisms can be used or modified for use with systems,apparatuses, and methods, including suture passers for tongue and othertissue compression as described in U.S. Pat. Pub. No. 2011/0245850 A1.The term “suture” as used herein, unless otherwise specified or limited,is intended to have its ordinary meaning and is also intended to includeall structures, including any of the aforementioned or later-describedexamples, that can be passed through tissue using the devices describedherein. One example of tissue that can be suspended or compressed is thegenioglossus muscle of the tongue. Such a system could be useful intreating a wide range of conditions, including, for example, obstructivesleep apnea. Other non-limiting examples of tissues that can besuspended or compressed include using systems and methods as describedherein include facial soft tissue such as in the forehead, brow, midface, jowls, lateral face, lips, eyelids, nose, and neck to treatwrinkles or asymmetry; the breast and/or nipple-areola complex to treatptosis; the bladder, such as the bladder neck to treat incontinence or acystocele; the uterus or vagina to treat prolapse; or muscles, tendons,and/or ligaments to treat a partial or complete tear. The suture passersystem could be used to ligate blood vessels such as arteries or veinsthat are not easily accessible without a surgical access procedure.Other non-limiting examples of anatomical structures that can besuspended other luminal structures such as a lymphatic, fallopian tube,bile duct, or ureter; or an organ such as, for example, the esophagus,stomach, small intestine, colon, rectum, bladder, uterus, vagina, eye,liver, lung, gallbladder, spleen, pancreas, or kidney. The suture passercan also be used to suspend other structures located within tissue, suchas bone, as will be described further below.

FIGS. 1A-1C illustrate one embodiment of a “threadedless” cammed boneanchor design that has the advantage of eliminating the need to thread atether, e.g., a suture 2102 to be anchored through the bone anchoreyelet. This can be accomplished by eliminating a portion 2110 of thetop of the bone anchor insert piece 2112 and also creating appropriategrooves 2114 in the outside wall of the bone anchor body 2104. Thesuture 2102, bone anchor body 2104, and insert 2112 are illustrated, aswell as insert loading pin 2108. FIG. 1A illustrates a verticalcross-sectional view of the cammed design in the open state. FIG. 1Billustrates the insert rotated 90-180 degrees with respect to FIG. 1A,with the cammed anchor in the closed position. FIG. 1C is a top viewthat also illustrates slots 2114 in the body for laying in and loadingsuture 2102; the insert 2112; and a hex engagement 2116.

FIGS. 2A-2F illustrate an embodiment of a bone anchor design 200 0configured to secure a tether. A tether is passed through the eyelet 206in the open configuration, as illustrated in the top view (FIG. 2A), aside view (FIG. 2B), and a side partial sectional view (FIG. 2C). Asillustrated in FIG. 2A, an inner member or core 202 ismoveable/rotatable with respect to the outer member 204. Placing thebone anchor insert in the closed configuration, as illustrated in thetop view (FIG. 2D), a side view (FIG. 2E), and a side partial sectionalview (FIG. 2F) secures the tether between surfaces within the boneanchor. As illustrated, when the core 202 is rotated, a tortuous pathresults in a small path/gap 208 between the outer diameter of the coreand the inner diameter of the outer member which pinches and locks thesuture in place.

FIG. 3 illustrates an embodiment of a suspension line 300 that includesa tether 301, knots 1302 or other features to improve adhesion betweenthe molded segment 304 and the tether 301, a radio-opaque marker 303,and molded segment 304. The tether 301, which can be a suture, forms abackbone of the suspension line 300 and in some embodiments may becontinuous underneath the overmolded segment 304 or discontinuous with amolded segment 304 molded over a plurality of discrete suture segments.Also shown is an axial length 312 of the suspension line 300. Theovermolded segment 304 could have a length 310 that is somewhat lessthan the length 312 of the total suspension line 300, and include a mainbody length 306 with a first diameter, and a tapered segment 308 havinga second diameter that tapers, e.g., gradually from the central mainbody length 306 to first and second lateral ends 314, 314′ of thesuspension line 300, the second diameter being less than the firstdiameter.

FIG. 4 illustrates another embodiment of a suspension line 400, somewhatsimilar to FIG. 3, showing a suture backbone 402 that can be braided,and a central molded segment 408 that may be made of a suitable materialsuch as silicone, and have a cylindrical cross-section that taperslaterally. A radiopaque marker 406 can be present on the suspension line400, such as under the silicone overmolded segment 408. The braidedsuture backbone 402 can have one or more knots 404 that canadvantageously help to maintain the position of the marker 406 andincrease adhesion with the molded material.

FIGS. 5-6 illustrate embodiments of “suture coil” composite suspensionlines 500 where a first suture 506, e.g., a #2 suture continuously runsthe length of the suspension line and a second larger suture 502, suchas a #9 suture is used to bulk up the middle section of the suspensionline. As illustrated in FIG. 5, the #2 suture 506 exits from the #9suture 502 and is wrapped around the #9 suture 502. The #2 suture 506 isthreaded down the midline of the #9 suture 502. The tips 504 of the #9suture 502 can be melted and shaped to provide a tapered transition andalso to provide anchoring of the #2 suture 506. In some embodiments, the#2 suture 506 may pull through the #9 braid 502 if it were not meltedinto a solid mass at the tips 504. The tapered section 504 also providesa transition from the smaller #2 suture 506 diameter up to the bulked upand coiled midsection 502. This transition 504 in some embodiments helpsthe suspension line 500 be easily passed through a path through tissueand prevent tissue ingrowth into parts of the structure.

In some embodiments, advantages of this design include providing acontinuous first suture with a first, relatively smaller diameter, e.g.,a #2 suture to ensure the strength of the loop and eliminating junctionsthat may reduce reliability. Also, the ability to securely “bulk up” asuspension line can be advantageous. Furthermore, the bulked-upconfigurations may be coated in silicone or another layer to furthersmooth transitions. The larger suture may also be glued or otherwiseattached to the underlying suture. As illustrated in the suture coil 600embodiment of FIG. 6, the #2 suture 602 is threaded all of the waythrough the midline of the larger #9 suture 604. Melted and molded tips606 as indicated provide a transition. Similar to FIG. 5, the #2 suture602 is threaded all of the way through the midline of the larger #9suture 604. Knots 608 or other means can secure the #9 suture 604 alongits length.

FIG. 7A-7E illustrate various elastic anchor embodiments. As illustratedin FIG. 7A, an elastic element 1702 in the tongue 200 operably connectedto a suture line 1700, which in turn can be connected to a structuresuch as the mandible 302. The elastic element 1702 can stretch underload to accommodate swallowing/speech. As illustrated in FIG. 7B, asuture 1700 can have an unstretched portion 1701 molded into anelastomer 1703, forming elastic element 1702. FIGS. 7C and 7D illustratethe embodiment of FIG. 7B partially and fully stretched, respectively;the suture 1700 limiting the amount of stretch. FIG. 7E illustrates aschematic graph of force vs. displacement, also showing the displacementlimit of the suture.

FIGS. 7F-7G illustrate additional elastic suture embodiments. As shownin FIG. 7F, axially compressing a suture 1721 made of a woven-braidedmaterial, e.g., in the direction of arrows 1720, then impregnating withan elastomer can give a similar effect of limited elasticity. The suture1721 can include an expanded region 1722 with elastomer impregnatedbetween suture 1721 fibers. When stretched, the elastomer will elongateand return to the compressed shape after the stretch force is released.FIG. 7G illustrates a suture 1730 having a central coiled section 1731surrounded by an elastomer 1732.

In some embodiments, the stretch element can provide limited complianceto allow for easier swallowing while still providing suspension forsleep apnea resolution. Some embodiments including limited compliancestretch elements are illustrated in FIGS. 8A-D. As illustrated in FIG.8A, the suspension line 800 includes a ribbon 802 with a central portion803 including an elastomer 804, and can be stretched as shown in FIG. 8Ban axial length X greater than the unstretched length 803. As shown inFIG. 8C, a suspension line 810 can include a woven ribbon 812 with anexpanded weave central portion 814, and an elastomer 816 operablyconnected to, such as impregnated into the weave 814. FIG. 8Dillustrates the suspension line 810 in an axially stretchedconfiguration, showing the weave at the limit of axial stretch.

In some embodiments, as illustrated in FIG. 9A, the tether 900 caninclude mechanical elements 902 that can be, for example, drops ofadhesive that wick into structures of, e.g., ribbon 904 or impregnatedsilicone, that may be essentially localized stiff sections. Themechanical elements 902 can also be larger than the ribbon 904 in someembodiments. Spacing the elements a distance X is large enough thatflexibility is maintained so a ribbon 904 can curve around a bend, butalso small enough to prevent twisting and collapse of the ribbon 904. Itmay be desirable to have stretch elements 924 in an otherwisenon-compliant suspension ribbon 922, as illustrated in the suspensionline 920 shown in FIG. 9B.

FIG. 10 illustrates an additional suspension line 1000 embodiment. Thereis a perception by some surgeons that a small diameter suture (e.g., #1or #2 USP, about 0.5 mm) could potentially migrate through the tonguewhen the suture has tension applied acting in the anterior direction.One means to address this perception is to place a larger suture in thetongue such that a given applied tension results in a lower pressureagainst the genioglossus muscle because of the larger area projection ofthe suture. In some embodiments, simply using a larger suture may not beideal because of the interface between the suture and the bone anchorthat attaches the suture to bone. A larger suture will require a largerbone anchor. A suspension line 1000 with small diameter/thickness tails1002 with an intermediary large diameter/thickness segment 1004 ispreferred in some embodiments.

FIG. 11 illustrates another suspension line embodiment 1100. The smalldiameter tails 1101 can be standard braided or monofilament suturelengths. The larger diameter section 1102 can be created by, forexample:

-   -   bulking up the braided suture by inserting a plastic, metal, or        other component into the braiding process such that the suture        fibers braid around the inserted body.    -   Bulking up a monofilament can be accomplished by adding        additional material on the main spine and/or intermittently        changing the drawing parameters of the monofilament to allow for        material to accumulate at specific locations.    -   Adding more fibers to the braid or altering the braid in some        way to allow the diameter of suture to grow at defined        locations.

The cross-section of the suspension line 1100 along its length can besubstantially round, oval, or other shapes in some embodiments. In someembodiments, there can be a transition region 1104 on either/both sidesof the large diameter section 1102. The small diameter suture 1101 mayor may not need to be continuous throughout the length of the suspensionline 1100.

FIG. 12 illustrates another embodiment of a suspension line 1200. Thesmall diameter tails 1201 of the line 1200 can be standard braidedsuture or monofilament suture for example. A silicone (or similarmaterial) hammock 1202 can be molded over the suture 1204 to create alarge section 1203. The hammock 1202 can have a substantially round orrectangular profile with a thickness and width. In some embodiments, thethickness could be less than the width in order to have a preferredbending direction once the tails of the suture are tensioned. In someembodiments, the small diameter suture 1204 could be USP #2, or about0.020″ or less in diameter. In some embodiments, the largediameter/thick sections 1202 could be between about 0.080″ to 0.120″, or0.020″ to 0.030″×0.080″ to 0.120″ as illustrated. In some embodiments,the lengths of the large diameter/thick sections 1202 could be betweenabout 2 cm and about 3 cm. The length of the taper 1205 could be, forexample, less than 1 cm, or less than 0.5 cm. In some embodiments, thesmall diameter suture 1204 could be USP #3, or about 0.024″ or less indiameter. In some embodiments, the large diameter/thick sections 1202could be between about 0.030″ to 0.200″, or 0.020″ to 0.030″×0.030″ to0.200″, or have a diameter that it at least about 20%, 30%, 40%, 50%,60%, 75%, 100%, 125%, 150%, 200%, or more larger than that of the smalldiameter suture 1204. In some embodiments, the lengths of the largediameter/thick sections 1202 could be between about 1 cm and about 5 cm.The length of the taper 1205 on either side of the largestdiameter/thickest section 1202 could be up to about 20%, 30%, 40%, or50% of the length of the entire large diameter/thick section 1202.

The surface of any of the disclosed suspension lines may bemechanically, chemically, or otherwise modified to improve adhesionwith, for example, muscle cells and other tissues of the genioglossus.Mechanical modifications create improved adhesion by modifying thesurface texture of the implant and may be achieved as part of themanufacturing process and may involve the removal of material from, orthe addition of material to the surface of the implant. Chemicaladhesion may be achieved through the incorporation of chemical(including biological) compounds into the surface or the bulk materialor materials that makes up the implant in order to improve the affinitybetween cellular components and the implant. Compounds may include, butare not limited to proteins, peptides, antibodies, growth factors, orother molecules which create an affinity for cellular or tissuecomponents.

FIGS. 13A-13B illustrate a suture loop 1300 placed in the tongue 200having a suture lock mechanism 1302. If it is not desirable to placebone anchors in the mandible, then a potentially less invasive andeffective implant could be to form a complete loop within the tonguebase which may then be tensioned to compress the tissue of the tongue200. As illustrated in the embodiment shown in FIG. 13A, a simple sutureloop 1300 is placed then tensioned to compress the tongue 200. A suturelock mechanism 1302 can maintain the desired tension. As illustrated inthe embodiment of FIG. 13B, a “hammocked” suture loop 1306 with broaderends 1308 relative to the central sections 1310 are placed and thentensioned to compress the tissues of the tongue 200. Multiple loops 1300can be placed and tensioned to better control advancement of the tongue200. Also, elastic suture material may be used in order to providenormal tongue function while preventing tongue base collapse that causeapnea and hypopnea. The suspension lock mechanism 1302 is meant to beknotless in some embodiments and to allow for changes in tension ifdesired over time.

In some embodiments, as illustrated in FIG. 14, the suture passer 100can be inserted into the tissue 200 in a generally vertical orientation,that is, the straight-line distance between the distal tip of the firstelongate shaft 102 and the distal tip of the second elongate shaft 106falls along a generally superior-inferior axis.

In some embodiments, as illustrated in FIG. 15, a plurality ofvertically-oriented suture loops 105, such as at least 2, 3, 4, 5, 6, ormore suture loops can be created in the tissue 200 by advancing thesuture passer 100 in a generally vertical orientation as in FIG. 14, andrepeating steps. In some embodiments, the suture loops 105 could bewithin about 10 degrees of the vertical axis. However, in otherembodiments, the suture loops 105 could be within about 75, 60, 45, 40,35, 30, 25, 20, or less degrees of the vertical axis. This provides morelocalized control of tissue suspension, depending on the desiredclinical result. In some embodiments, a combination ofhorizontally-oriented and vertically-oriented suture loops can be used,or just horizontally-oriented suture loops. In some tongue embodiments,the distance between suture loops 105 could be irregular or regular. Thedistance between the midlines of the suture loops 105 could be, forexample, between about 0.1 cm and about 3 cm. The multiple suture loops105 may also have the same or differing orientations within the tissue200. In some instances where additional suture strength is required at asingle location within tissue, the multiple suture loops may share amidline axis, as illustrated in FIGS. 15A-15D, but have loops orienteddifferently (from 0 to +90 degrees) from each other. FIG. 15Aillustrates schematically a first suture pass 105 a through tissue,while FIG. 15B illustrates both a first suture pass 105 a and a secondsuture pass 105 b sharing a common midline axis 105×. FIG. 15Cillustrates an end view of FIG. 15B, while FIG. 15D illustrates a sideview of FIG. 15B.

Substantially vertical suture loop(s) placed at the midline of thetongue base may have additional advantageous as therapy for preventingan apnea event. First, by acting on the midline, the suture loop is lesslikely to affect the lateral walls of the pharynx. Second, if there iscollapse of the tongue base against the posterior wall of the pharynx,the tissue may be “tented” at the midline, maintaining at least somepathway for air and avoiding complete obstruction of the pharynx. Thisis similar to the effect seen with a midline glossectomy.

Tissue 200 may be suspended by securing the free ends of suture loop(s)105 to a structure such as a bone anchor (e.g., implanted in themandible or hyoid bone) or other body structure outside the tissue 200.Other body structures in which the suture loop could be attached toinclude, for example, the hyoid bone or the soft palate. Alternatively,the free ends of suture may be tied in a knot or otherwise secured tosuspend the tissue 200.

When tongue suspension is desired, the tongue could be accessed via theoral cavity. In some instances, embodiments of the tongue suspensionsystem can be implanted through an antero-inferior access site of themandible. Implantation of the system that avoids the transoral route mayimprove infection rates that occur with other tongue related devices andprocedures.

A description of pharyngeal anatomy and a method for suspending thetongue will now be described. FIG. 15E is a sagittal view of thestructures that comprise the pharyngeal airway and may be involved inobstructive sleep apnea. The pharynx is divided, from superior toinferior, into the nasopharynx 1, the oropharynx 2 and the hypopharynx3. The nasopharynx 1 is a less common source of obstruction in OSA. Thenasopharynx is the portion of the pharynx above the soft palate 4. Inthe nasopharynx, a deviated nasal septum 5 or enlarged nasal turbinates6 may occasionally contribute to upper airway resistance or blockage.Only rarely, a nasal mass, such as a polyp, cyst or tumor may be asource of obstruction.

The oropharynx 2 comprises structures from the soft palate 4 to theupper border of the epiglottis 7 and includes the hard palate 8, tongue200, tonsils 10, palatoglossal arch 11, the posterior pharyngeal wall 12and the mandible 302. The mandible typically has a bone thickness ofabout 5 mm to about 10 mm anteriorly with similar thicknesses laterally.An obstruction in the oropharynx 2 may result when the tongue 200 isdisplaced posteriorly during sleep as a consequence of reduced muscleactivity during REM sleep. The displaced tongue 200 may push the softpalate 4 posteriorly and may seal off the nasopharynx 1 from theoropharynx 2. The tongue 200 may also contact the posterior pharyngealwall 12, which causes further airway obstruction.

The hypopharynx 3 comprises the region from the upper border of theepiglottis 7 to the inferior border of the cricoid cartilage 14. Thehypopharynx 3 further comprises the hyoid bone 15, a U-shaped, freefloating bone that does not articulate with any other bone. The hyoidbone 15 is attached to surrounding structures by various muscles andconnective tissues. The hyoid bone 15 lies inferior to the tongue 200and superior to the thyroid cartilage 16. A thyrohyoid membrane 17 and athyrohyoid muscle 18 attaches to the inferior border of the hyoid 15 andthe superior border of the thyroid cartilage 16. The epiglottis 7 isinfero-posterior to the hyoid bone 15 and attaches to the hyoid bone bya median hyoepiglottic ligament 19. The hyoid bone attaches anteriorlyto the infero-posterior aspect of the mandible 302 by the geniohyoidmuscle 20.

Methods of treating a condition of an airway will now be described. Forexample, the method can comprise creating a first pathway within thetongue 200 without passing through the mucosa, and creating a secondpathway within the tongue 200. For example, FIG. 15E depicts oneembodiment of the invention where the suture passer 700 is inserted intothe tongue 200 through an insertion site inferior to the mandible 302,which could be but is not necessarily about the anterior portion of themandible 302. In other embodiments, the implantation pathway mayoriginate from a location anterior or lateral to the mandible 302, andin still other embodiments, may also pass through the mandible 302. Thesuture passer 700 may be inserted percutaneously to create the firstpathway and the second pathway. Prior to insertion of the suture passer700, optionally a guide catheter, needle, or other piercing deliverytool known in the art could be initially placed, and followed by aguidewire. The method can further comprise passing a flexible elongatemember (e.g., suture loop) extending through the first pathway throughthe tongue tissue from the first pathway to the second pathway. In someinstances, the distal portion of the suture loop is positioned about thebase of the tongue, which is the portion of the tongue posterior to thecircumvallate papillae (not shown), but other locations within thetongue 200, such as the anterior portion 39, may also be used. Forexample, the loop portion of the suture loop may also be positioned inthe dorsal region 38 of the tongue 200. When the suture loop iswithdrawn from the second pathway, the suture loop forms a looped paththrough the tongue 200.

In FIG. 15E, the embodiment of the suture passer 700 can have adual-shaft configuration with a single actuator control 701 at aproximal end. The suture passer 700 also has a body 703 housingdifferent mechanical components, including secondary control 711 along asidewall of the body 703. Suture passer 700 may also include fingergrips 713 extending from opposite sidewalls of the body 703. A firstelongate shaft 702 and a second elongate shaft 706 extend distally fromthe body 703.

Steps as illustrated in FIGS. 15F-15J can be described in connectionwith formation of a suture loop via use of a suture passer completelywithin the tissue 200. A suture 105 is passed through the base of thetongue 200 using, for example, a suture passer 700 or any otherembodiment of a suture passer as described elsewhere. FIGS. 15F-15N showa procedure and sequential steps for anterior suspension of the tongue200. As illustrated in FIG. 15F, the suture passer 700 is advanceddistally into tissue of the base of the tongue 200 without passingthrough the tongue mucosa. The suture passer 700 can be inserted intothe tongue 200 at an angle to the superior-inferior axis. The firstelongate shaft 702 may be positioned inferiorly relative to the secondelongate shaft 706 as the suture passer 700 is delivered distally intothe base of the tongue 200. Next, shown in FIG. 15G, a flexible needle704 carrying the suture 105 is advanced through a window of asuture-capturing element 708. As illustrated in FIG. 15H, the flexibleneedle 704 is retracted back into the first elongate shaft 702, leavingthe suture 105 in the capture window, such as when a movable panel ofthe second elongate shaft 706 slides against an end of the window,closing the window. As shown in FIGS. 15I-15J, the suture passer 700 iswithdrawn to leave behind the suture 105 in the tissue 200.

When suspending the tongue and advancing the genioglossus anteriorly,the precise placement and tensioning of an implant can avoid potentiallyincreasing potential lateral collapse of the pharynx. Furthermore,tongue suspension using the methods and devices as disclosed herein canbe advantageous as the procedure, in at least some embodiments, can befully reversible by simply removing the suture(s).

In FIGS. 15K-15N, a method of inserting another structure or tensionelement, such as a suture within the tongue 200 is provided. Uponrelease of the suture 105 from the suture passer 100, the suture 105 mayinclude a closed end 105 b and free ends 105 c. The suture 105 a maypass through and be secured to the closed end 105 b of the suture 105.When the suture 105 is pulled from the free ends 105 c, the suture 105 ais drawn into the tongue 200 and toward the dorsal region 38. The suture105 a positioned in the tongue 200 can add strength and greater tension,based at least in part on its size and/or material properties, so as toprovide additional tissue control. In some embodiments, the suture 105 ais a tension element that is thicker than the suture 105. Moreover, thefirst suture 105 can be a guide suture or a suture loop having a widththat is less than 90%, 80%, 70%, 60%, 50%, or less of the tensionelement 105 a. The tension element 105 a can be advanced toward theanterior portion 39 to further suspend the tongue 200 and advance thegenioglossus anteriorly. The tension element 105 a can be secured via abone anchor 300.

As illustrated in FIG. 15N, a bone anchor 300 could be implanted nearthe midline of the mandible 302 as shown, and the free ends of thetether 105 a then attached thereto. In the method shown in FIGS.15F-15N, the free ends of the 105 a do not need to be pre-attached tothe bone anchor 300, allowing for additional convenience and ease increating the appropriate tension in the suture loop. The bone anchor300, when inserted into the mandible 302 is typically located about ananterior portion of the mandible 302 and may involve the external,internal or inferior surface of the mandible 302 or a combination ofthese surfaces. In some embodiments, a lateral or anterolateral locationabout the mandible 302 may be used.

With reference to FIGS. 15O-15R, a method of passing multiple sutureloops through the tongue, such as the posterior portion of the tongue,is provided. FIG. 15O illustrates a schematic sagittal cross-sectionalview of a tongue 200. Above the oral cavity 204 is the palate 206, andposterior to the tongue 200 is a pharyngeal wall 208. The tongue 200abuts the mandible 302 anteriorly.

Still referring to FIG. 15O, using a suture passer 100, which can be,for example, as previously described, a first suture loop 105′ having afirst end 1051 and a second end 1052 is passed through the tongue 200 ina generally anterior-to-posterior direction. However, the first end 1052of the suture loop 105′ is reintroduced onto the suture passer asillustrated in FIG. 15P and is again passed into the tongue 200. Inother embodiments, a second discrete suture could be passed instead ofthe first end of the first suture simply reintroduced onto the suturepasser. In some embodiments, one or more of suture loops 105′, 105″ maybe vertically oriented as described in FIG. 15, or oriented in ahorizontal plane, or at other various angles as previously described.

In FIG. 15Q, a second suture loop 105″ is passed through the tongue 200to provide additional tissue control. As with the first suture loop105′, the second suture loop 105″ does not pass all the way through thetongue posteriorly. In some embodiments, the second suture loop 105″passes along substantially the same path as or near the same path as thefirst suture loop 105′, or through different paths, such as described,for example, in connection with FIGS. 15A-15D above. Additionally, atleast 3, 4, 5, 6, 7, 8, or more suture loops can be created in thetongue 200 by repeating the suture passing procedure to provide evenmore anchoring control.

In FIG. 15R, a tension force (T) is applied to the free ends 1051, 1052of the suture loops 105′, 105″ to effectively compress and/or shortenthe anterior-posterior dimensions of the tongue 200. The free ends 1051,1052 could then be tied within the tongue 200, obviating the need for abone anchor, or alternatively secured to a surrounding structure such asthe mandible 302 and/or hyoid bone. In some embodiments, the tongue 200may be compressed in the anterior-posterior direction by at least about2%, 3%, 5%, 10%, 20%, 30%, or more. In the embodiment where the suture105 is secured to the mandible 302 or to a bone anchor in the mandible,this single surgical technique provides two types of therapy to thetongue 200. The outer suture loop 105′ (whose loop segments are closestto the end of the suture) acts to suspend the tongue 200 as describedpreviously. The inner suture loop 105″ (whose loop segment is nearestthe midline of the suture) acts to compress the tissue within the tongue200. This combined therapy from a single suture 105 may be particularlyadvantageous in patients with overly large tongues or with obesepatients whose tongues have additional fatty deposits within thegenioglossus. As a result, the procedure can increase the size of theoral cavity 204 by advancing the tongue 200 forward, which could relieveairway obstruction.

As noted, systems and methods described herein can be used to suspendany biological structure such as tissue. FIGS. 15S-15W schematicallyillustrate a method of using a suture passer to suspend an anatomicalstructure that may not be tissue. As previously mentioned, theanatomical structure could be, for example, a tubular structure such asa blood vessel, or various other structures disclosed elsewhere herein.FIG. 15S schematically illustrates a cross-section of a structure 199spaced apart from a tissue surface 198. As shown in FIG. 15T, the suturepasser 100 is deployed, such as into tissue 198, and positioned to passthe suture 105 around the structure 199. The suture 105 is then passedaround structure 199 from suture-passing element (e.g., needle 104) tosuture-receiving element 108 (such as a snare or capture window), asillustrated in FIG. 15U. The suture-passing element 104 is thenretracted, and the suture-receiving element 108 transformed to capturethe suture 105, as illustrated in FIG. 15V. The suture passer 100 isthen retracted and removed as shown in FIG. 15W, and tension formed onthe suture loop 105. The structure 199 can then be suspended to ananchoring structure (not shown) such as, for example, a bone anchor,tissue anchor, or tied in a loop within the tissue 198.

It is contemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment can be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the invention issusceptible to various modifications, and alternative forms, specificexamples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “passing a suspension line through the base of thetongue” include “instructing the passing of a suspension line throughthe base of the tongue.” The ranges disclosed herein also encompass anyand all overlap, sub-ranges, and combinations thereof. Language such as“up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“approximately”, “about”, and “substantially” as used herein include therecited numbers, and also represent an amount close to the stated amountthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately”, “about”, and “substantially” mayrefer to an amount that is within less than 10% of, within less than 5%of, within less than 1% of, within less than 0.1% of, and within lessthan 0.01% of the stated amount.

What is claimed is:
 1. A variable-thickness suspension line forsuspending tissue, comprising: a suture having a first thicknessdimension; an elastomer surrounding a portion of the suture and defininga central segment of the suspension line having a second thicknessdimension greater than the first thickness dimension, and at least onetransition zone extending from the central segment of the suspensionline to a lateral end of the suspension line, the transition zoneshaving a thickness dimension that tapers from the second thicknessdimension to the first thickness dimension.
 2. The suspension line ofclaim 1, further comprising a plurality of transition zones, eachtransition zone extending from the central segment of the suspensionline to respective lateral ends of the suspension line.
 3. Thesuspension line of claim 1, wherein the elastomer is overmolded onto thesuture.
 4. The suspension line of claim 1, wherein the elastomercomprises silicone.
 5. The suspension line of claim 1, wherein thesuture is braided.
 6. The suspension line of claim 1, further comprisinga radiopaque marker operably attached to the suture.
 7. The suspensionline of claim 1, wherein the radiopaque marker is disposed on thecentral segment of the suspension line.
 8. The suspension line of claim1, wherein the suture extends axially along the entire length of thesuspension line;
 9. The suspension line of claim 1, wherein theelastomer is overmolded over a plurality of discontinuous segments ofthe suture.
 10. The suspension line of claim 1, wherein the centralsegment of the suspension line comprises one or more knots for improvingadhesion between the suture and the elastomer.
 11. The suspension lineof claim 1, comprising a rounded cross-section.
 12. The suspension lineof claim 1, comprising a rectangular cross-section.
 13. The suspensionline of claim 1, wherein the central segment is configured to movebetween a first axially unstretched configuration and a second axiallystretched configuration.
 14. A variable-thickness suspension line forsuspending tissue, comprising: a tether having a first thicknessdimension, the tether having first and second lateral ends and a centralsegment; an elastomer surrounding and overmolded to the central segmentof the tether and defining a central zone of the suspension line, thecentral zone having a second thickness dimension greater than the firstthickness dimension.
 15. A method for performing glossopexy, comprising:providing a variable-thickness suspension line comprising: a suturehaving a first thickness dimension, the suture extending axially alongthe suspension line; and an elastomer surrounding and overmolded to asegment of the suture, defining a central segment of the suspension linehaving a second thickness dimension greater than the first thicknessdimension; and wherein areas of the suture not surrounded by theelastomer define lateral ends of the suspension line; passing thesuspension line through the base of the tongue to form a loop in thesuspension line; and tensioning the suspension line to suspend thetongue.
 16. The method of claim 15, further comprising securing thesuspension line to the mandible.